Surgical system for controlling the infusion of fluid to and the evacuation of fluid and material from an operating field

ABSTRACT

A system for controlling the infusion of fluid to an operating field at a selected predetermined pressure, as a counterpart to an instrument for severing material from an object in the field, and for evacuating the severed material from the field in a suspension or emulsion of the infusion fluid. The system includes safety features for preventing a low pressure in the operating field, to thereby prevent a surge of fluid from the field, and referencing infusion and evacuation pressures to that of the operating field. In addition, the basic electrical functions of the entire system are operated by a single control.

United States Patent [191 Banko i [451 Nov. 18,1975

[ SURGICAL SYSTEM FOR CONTROLLING THE INFUSION OF FLUID TO AND THE EVACUATION OF FLUID AND MATERIAL FROM AN OPERATING FIELD Related US. Application Data [63] Continuation-impart of Ser. "No. 208,282, Dec. 15,

1971, Pat. NO. 3,812,855.

[52] US. Cl. 128/230; 128/276 [51] Int. Cl. A61M l/00 [58] Field of Search 128/230, 276, 277, 278,

[56] References Cited UNITED STATES PATENTS 7/1953 Hu 128/276 X 2/1969 Romanelli 128/230 X 3,513,846 5/1970 Gallo 128/276 X 3,599,639 8/1971 Spotz 128/276 3,788,305 l/1974 Schreiber 128/276 X 3,812,855 5/1974 Banko 128/276 X Primary ExaminerRichard A. Gaudet Assistant Examiner-l Yasko Attorney, Agent, or FirmDarby & Darby [57] ABSTRACT A system for controlling the infusion of fluid to an operating field at a selected predetermined pressure, as a counterpart to an instrument for severing material from an object in the field, and for evacuating the severed material from the field in a suspension or emulsion of the infusion fluid. The system includes safety features for preventing a low pressure in the operating field, to thereby prevent a surge of fluid from the field, and referencing infusion and evacuation pressures to that of the operating field. In addition, the basic electrical functions of the entire system are operated by a single control.

29 Claims, 3 Drawing Figures U.S. Patent Nov. 18,1975 Sheet10f2 3,920,014

Sheet 2 0f 2 FIG. 3

EVAC- MECH. PRESSURE 82 TXDR EVAC. ELECTRICAL CONTROLLER 92] 69 REJERSE READOUT E. M. VALVE 76 BUD READOUT [11:1 :1 1:10

INFUSION E. M. VALVE as 82 PRESSURE PRESSURE 1 TXDR TXDR pRgsagRE IIIHIHHHHII SURGICAL SYSTEM FOR CONTROLLING THE INFUSION OF FLUID TO AND THE EVACUATION OF FLUID AND MATERIAL FROM AN OPERATING FIELD This application is a continuation-in-part of my prior copending application Ser. No. 208,282, filed Dec. 15, 1971, now US. Pat. No. 3,812,855 entitled SYS- TEM FOR CONTROLLING FLUID AND SUCTION PRESSURE which is assigned to the same assignee.

This invention relates to a surgical apparatus and more particularly to an apparatus having particular utility in an operation taking place in a closed operating field, such as the eye of an animal or human being.

In my aforesaid prior application, a system is disclosed for use in conjunction with a surgical instrument of the type which can remove material from an object, such as by cutting, drilling, emulsifying such as by using ultrasonic energy, tearing, etc. The system operates to infuse fluid in an operating field for certain purposes, such as to maintain a predetermined pressure, and also for evacuating from the field the severed material removed from the object in suspension with or as an emulsion of the infusion fluid.

The present invention relates to an improved system of the type disclosed and claimed in the foregoing application. The system of the subject invention is capable of performing a variety of functions all under the control of an operator. Among these are the supply of a fluid to the operating field at a selected predetermined pressure after the surgical instrument is inserted to keep the operating field, for example the eye, formed in its normal physical shape both before and during the operation. During the operation the system also: (1) creates an evacuation flow for transportation of the material severed by the surgical instrument, which material is suspended or is emulsified in the supplied fluid and in the normal fluid of the operating field; (2) substitutes fluid to compensate for the volume of material, both solid and liquid, removed from the operating field; and (3) maintains the pressure in the operating field within workable and safe tolerance levels.

The system also can be operated to generate a reverse flow of fluid through the instrument into an operative portion thereof when material being removed inadvertently has entered the instrument and has to be moved back into the operating field. As a safety feathe operating field into the instrument. This prevents the operating field from being emptied of material which would ultimately cause it to collapse. In addition, the system controls the operationof a cutting or emu]- sifying means to be either: in a ready condition; in an operative condition during the conduct of the operation; or, in the case where a movable cutter is used, to move the cutter in the reverse direction during the application of fluid in the reverse mode.

It is therefore an object of the present invention to provide a novel surgical system for controlling the infusion of fluid to an operating field, the rate of separationor cutting of material from the object being operated on, and the evacuation of fluid and material from the operating field. I

A further object is to provide a liquid infusion and material evacuating system for use in connection with a 2 surgical instrument for removing material from an objectv An additional object is to provide a system utilizing easily operated control members for controlling the infusion of fluid-and the evacuation of fluid and material from an operating field.

Another object is to provide a liquid infusion and material evacuating system for use with a surgical instrument in which safety features are provided to prevent an unsafe overpressure or an underpressure condition.

Other objects and advantages of the present invention will become more apparent upon reference to the following specification and annexed drawings, in which:

FIG. 1 is an overall plan view, taken partly in crosssection, of a typical instrument for use with the system of the present invention;

FIG. 2 is a schematic line diagram showing the various components of the system and their operation, with particular emphasis on the fluid flow portions of the system and their various components; and;

FIG. 3 is a schematic diagram of the system particularly illustrating the electronic control function of the system.

Referring to the drawings, the system is described with respect to performing an operation on the eye of an animal or a human being. It should be understood, of course, that the system can be utilized with at any performance of operations and other types of environments. 7

FIG. 1 shows a typical surgical instrument 10 which can be used with the control. It should be understood, however, that the system can be used with any type of instrument or instrument set-up which requires pressurized flow of a liquid (infusion) and/or evacuation of fluid and severed material from an operating field.This includes various types of mechanical cutting instruments as well as other instruments, for example those of the ultrasonic type, which emulsify material to be removed.

In the embodiment of the invention being described, the tip of instrument 10 is shown as having pierced through asection of the eye, for example after an incision has been made. The tip of the instrument is shown in the vitreous of the eye to remove tissue therefrom or to treat the eye. The instrument of FIG. 1 also can be used to remove material from other parts of the eyesuch as the lens or iris. It should be understood that the system can be used with anycompatible type of instrument to perform operations or treatment in any portion of the body of a mammal.

The instrument 10 of FIG. 1 includes an electric motor 2, preferably of the reversible type, from which extends a collar 3. A fitting 4 is screwed onto collar 3 and concentric inner and outer tubular members 12 and 16 extend from fitting 4. Inner tube 12 defines a central passage 14 through which evacuationv takes place over a line 80, to be described below, which communicates with passage 14 through a coupling on-fitting 4. The space between the inner and the outer tubes 12 and 16 defines a passage 17 through which infusion fluid issupplied over a line 66 and reverse flow fluid over a line 70, both of which lines are described below. Lines 66 and 70 communicate with passage 17 through a common coupling in fitting 4.

The inner, evacuation flow, member 14 of the instrument has an opening 19 at the end thereof through which the evacuation flow is applied to the operation Field. The infusion flow member 16 has an opening 21 In its wall, spaced from opening 19 to avoid interference, through which fluid is injected into the operating field. A shaft 6 having a fluted cutter 7 at the end thereof is located in the inner passage 14. The shaft is connected to the motor output and rotates in bearings 8 in the fitting 4. Shaft 6 is preferably biased by a spring 9 so that the cutter 7 will coact with the surface surrounding the evacuation opening 19 to produce a shearing action to cut any tissue therebetween. In operation, the tip of the instrument is moved to place the cutter 7 at the site of the material to be severed. The evacuation flow from opening 19 aids in drawing the material into a relationship so that it can be severed by cutter 7. The severed material, in suspension or as part of an emulsion, is drawn up passage 14 and is removed via passage 14. Infusion fluid is supplied over line 66 to the eye through passage 17 and its opening 21.

The system of the invention regulates the flow of infusion fluid to provide a selected predetermined pres sure in the eye. In addition it maintains the evacuation flow rate to within predetermined safe limits. This is described below.

FIGS. 2 and 3, taken together show the fluid flow and electronic control system components of the system. In these figures, the double lines indicate fluid flow paths and the single lines electrical connections. The infusion fluid supply for the instrument I is illustratively shown as a bottle 60 having a calibrated scale thereon. In a typical case, saline solution is utilized as the fluid. The bottle 60 is capped at 62 so that it can be pressurized over a line 64 which extends into the bottle. The line 64 can be of any conventional type of tubing, for example, vinyl tubing, and it is connected to a compressor, or pump, 50. Pump 50 is any suitable type producing an air flow. The air entering the infusion bottle is preferably filtered by a suitable filtering means (now shown) to make it sterile. The pump 50, in conjunction with various regulating valves, produces a constant pressure in line 64 and bottle 60 within selectable, relatively well defined limits, which can be pre-set.

An infusion line 66 also extends into the bottle 60 to receive fluid therefrom to be conveyed to the outer passage of the instrument 10. This is the infusion fluid to such passage. An electromechanically controlled valve 68 is located in line 66 between bottle 60 and the instrument to control the fluid flow. Line 66 also can be of vinyl or other suitable material.

A second fluid line 70 also receives fluid from the bottle 60. This is the reverse fluid-flow line whose outlet end is connected to the instrument to supply fluid to the inner passage I6 of the instrument. An electromechanically operated valve 69 is located in line 70 between the bottle 60 and the outlet of reverse flow line 70 to control the flow of fluid to the outlet.

An evacuation mechanism 81 removes the severed or emulsified material from the eye through an evacuation line 80 which is connected to the inner passage of the instrument 10. The evacuation is carried out at a substantially constant rate, which can be selected and preset, to create a flow of material from the eye in a substantially gasless column of liquid. The evacuation mechanism preferably includes a peristaltic type pump, for example, the Master Flex Tubing Pump, Model 7013 made by Cole-Parmer Company, of Chicago, Illinois. The operation of this type of pump is described in greater detail below. Line 80 empties into a waste bottle 82 through the pump and a line 83. The material 4 emptied into bottle 82 includes fluid from the operating field together with the material severed from the object by the instrument.

Solenoid operated, pressure regulating valves 58, herein illustratively shown as three in number, 58a, 58b and 58c, are provided in the pressure line 64 to the bottle 60. Each of these valves has a pressure set adjustment, indicated by the arrow, to control or set the pressure in line 64 to the bottle and also to the instrument. Valves 58 are conventional solenoid operated valves having, for example, a needle adjustment to set the pressure when the valve is open.

As described in greater detail below, valve 58a controls the pressure (P in the infusion line 66 during the ready mode of the system..This is the lowest pressure. When valve 58a is operating, both the infusion line control valve 68 and the reverse flow line control valve 69 are open to prevent any flow of material from the eye into the instrument 10. Valve 58b sets the pressure greater than the pressure in the ready mode. During the operating mode the infusion line control valve 68 is open and the reverse flow line control valve 69 is closed. Valve 58c sets the pressure (P in the reverse flow line 70 during the reverse mode. This is the highest pressure. When valve 58c is open, the infusion control valve 68 is closed and the reverse line control valve 69 is open. As indicated above:

Each of the valves 58, 68 and 69 is of conventional construction and is operable to an open or a closed condition by a control circuit generally indicated at 84. The electric signals from the control circuit 84 are transmitted over signal lines, illustrated by the single lines, to the various valves to open and close them. In FIG. 2 the circuit 84 is illustrated in the form of a multideck switch. The three control portions are Operate on the left, Ready in the center, and Reverse to the right. The single lines back to the switch indicate that the particular component is energized. The switch can be a foot switch which has three positions corresponding to the ready, operate and reverse modes. The ready mode can be a neutral, or middle, position of the foot switch; operate the forward position and reverse the rear position.

FIG. 3 illustrates additional details of the electronic control system as well as additional components of the fluid control system. In FIG. 3, a tracking tube 82 is located physically above the level of the liquid supply bottle 60. The tracking tube 82 is essentially a manometer and can be mounted, for example, on a ring stand. The level of the liquid in the long arm of the tracking tube, which for example can be water, is set to the level of the eye being operated upon. The tracking tube pressure level is reflected in the infusion line 66, the reverse flow line 70 and the evacuation line 80, and is used to calibrate the pressure in these lines to a base, or reference, pressure. As described below, this is used to avoid excessive high or low pressure in either of these lines.

A pressure transducer 83 of any suitable conventional type is connected to the tracking tube 82. Transducer 83 converts the pressure in tracking tube 82 to an electrical output signal which is conveyed to an electronic digital readout device 90. The device is calibrated to visually display pressure in terms of mm of Hg. Any conventional readout device can be used, for example, one of the digital voltmeter type, made by Data Technology Corp. of Santa Anna, California,

Model 3212-02. Readout 90 receives a signal from a second transducer 85 which is connected in pressure line 64. Readout 90 is wired to display the difference between the two signals from transducers 85 and 83 so that its display represents the infusion pressure at the operating site. This is the actual pressure of the infusion fluid supplied to the eye. The output signal representative of this displayed pressure difference is also available at the output of readout 90 as an electrical signal.

The pressure above that in the bottle 60 which is required to raise the liquid level in the infusion line 66 and/or reverse flow line 70 to the level of the liquid in the tracking tube, which is at the same level as the eye physically, is indicated on readout 90 as the starting pressure, or zero. This is so when the liquid in the bottle 60 is at the designated height, which is usually at a nominal 1,000 cc level. When the level of fluid in the bottle drops, the reading of the readout 90 is excessive for the amount of drop of level (a given amount of millimeters of Hg).

Any raising, or lowering, of the pressure in the bottle 60 or the pressure'line 64 will raise, or lower, the level of the liquid in the infusion line 68 and the reverse flow line 70 and increase, or decrease, the pressure in the eye. During a typical operation, the amount of fluid used from the bottle 60 is relatively small so that the change in pressures caused by this is also minimal.

A pressure sensor 87 is also located in the evacuation flow line 80 to sense the pressure in the line and to produce an electrical signal representative of it. This signal is supplied to a second readout device 92 which also receives a signal from the tracking pressure transducer 83. Device 92 displays in digital form, calibrated in millimeters of Hg, the difference between the pressure in line 80 and the tracking tube pressure. That is, the readout of device 92 is the evacuation flow pressure referenced to the tracking pressure. An electrical signal representative of the latter pressure is present at the output of readout 92.

The evacuation mechanism 81 is to be operated to maintain a constant evacuation flow in line 80. As indicated previously, the mechanism includes a constant displacement type pump, which in the preferred embodiment is a peristaltic pump 120 (FIG. 2). This has a hemispherical housing portion 122 of rigid material and a flexible plastic tubing 124 within the housing against which a triple arm roller system 126 rotates.

The rollers 127 are spaced about 120 apart. The roller system 126 is rotated by a suitable motor (not shown) whose speed can be controlled. The inlet to pump 120 is the evacuation line 80 which is preferably a rigid plastic tubing. The outlet 83 of the pump is to the waste bottle 82.

The peristaltic pump 120 moves a column of liquid in a section A between two of its rollers 127, creating space for the contents of section B in tubing 80 between the instrument outlet and the closest roller 127 of pump 120 to the instrument. Rotation of the roller on the tubing in the pump 120 in area A creates a flow of material out of the pump exit passage 83. Fluid is being forced into the operating field at the time over the infusion line and up to the pump inlet.

When the peristaltic pump inlet is near the eye and the instrument is connected to the pump by a relatively short and rigid tube 80, then the displacement of fluid by the pump is communicated to the eye with negligible time delay imposed by a flow through the cutting opening 19 of the instrument.

The system operates in several distinct modes which are described below:

1. Ready Mode To produce this mode of operation the instrument is turned on and the electrical circuitry is such that the motor for the cutter of instrument 10 is off and the cutter does not rotate. Evacuation mechanism 81 is off but pressure pump 50 is operating. At the same time, valve 58a in the pressure line 64 is open and valves 58b and 580 are closed. Both the infusion line control valve 68 and the reverse pressure line control valve 69 are open. The valve 69 also can be controlled to close, by a signal from transducer 85, after the pressure in the evacuation line is close to or reaches the pressure in the eye.

In this mode the pressure of the fluid-flow in infusion line 66 is most limited, by valve 58a being open, and is being produced only to maintain the pressure in the operating field and to compensate for any leakage through the incision in the operating field and the instrument. This is normally something above the pressure level in the tracking tube, in the order of 15-20 mm of Hg above zero in a typical case of the example being described. In general, there is a small pressure drop in the infusion line 66 between bottle 60 and the instrument. In the ready mode, the pressure in the evacuation line 80, as indicated on readout 92 is equal to the pressure in the infusion line, as indicated by the readout 90, since both control valves 68 and 69 are open or if valve 69 is controlled to be closed. At the same time, only pressure regulatingvalve 58a is open, thereby producing the same pressure in both lines 66 and at the operating site, either through the connection of the evacuation and reverse flow lines at the instrument or at the fluid connection within the operating site provided by the-infusion and the evacuation ports of the instrument. The latter occurs when valve 69 is closed. When both valves 68 and 69 are open the pressure in the eye rapidly builds to the proper level to keep it formed. In a typical case where the eye is being operated on through anincision which is closed, so that the eye itself is essentially fluid-tight, this pressure is set at about l520 mm of Hg above atmospheric pressure. In an open sky operation, where the eye is open to the atmosphere, the pressure is kept at zero, or slightly above, to prevent outflow of material from the eye. A manually controlled switch (not shown) is also provided, to close both control valves 68 and 69 after lines 66 and 80 are filled with fluid. This prevents any movement of fluid into or out of the instrument which is especially useful during an open sky type operation.

2. Operating Mode This mode is obtained by having the operator of the system operate the foot switch, for example to the forward position. This completes electric circuits to turn on both thepressure pump 50, the evacuation mechanism 81 and to operate the instruments electric motor to turn the cutter in the forward direction. Where other types of instruments are used, for example an ultrasonic probe or turbo-fragmentator, these would be energized at this time. At the same time, the operating pressure valve 58b is opened and valves 58a and 58c are closed. Reverse flow line control valve 69 is closed and infusion line control valve 68 is opened.

As described previously, the rate of infusion fluid flow depends on the rate of evacuation. The maximum incoming rate of infusion fluid is limited so as not to create prohibitive streaming and consequent undesired displacement of floating tissue and other substance as n the operating field, generally near and around the ,:utting opening 19 of the instrument 10. A high velocity of the incoming infusion liquid is desirably avoided since it has a mass impulse which may damage delicate tissue in the operating field.

The pressure in the operating field is to be maintained within tolerable limits below a desired maximum level, usually less than 30-35 mm of Hg above the atmospheric pressure in the case of a normal operation on the eye. However, for example, in the case where there is bleeding in the eye, the pressure can be set to control the bleeding by increasing it to counteract the pressure of the blood being pumped by the heart. The evacuation system will also operate to remove the blood from the operating site permitting better visualization for cauterizingi After the latter is done, the pressure can be reduced and the operation continued. Therefore, the maximum rate of inflow of the infusion fluid must be controlled and, in some cases, limited, To accomplish this the evacuating system will not permit the evacuation to exceed a rate such that the pressure in the operating field can be maintained without creating undesirably high inflow rates of the infusion fluid.

During the operation mode the material separated by the instrument cutter is entrained in suspension in the infusion fluid and is moved to the waste bottle 83 by the evacuation mechanism 81. The operating pressure in the infusion line is established by valve 58b being opened. The pressure in the evacuation line 80 depends on several factors. These are: (l) the cross section of the inlet opening to the instrument, this changes where there is a movable cutter; (2) the flow rate of the evacuation mechanism itself; and (3) the viscosity of the infusion fluid and the material being removed.

The pump 120 is normally set to rotate at a constant speed to create a desired flow rate of fluid through the eye. The flow resistance through the instrument opening 19 and the rest of the evacuation line 80 is changing continuously during the operation. When the resistance increases, a greater force is needed to move a slightly smaller amount of suspension by the pump (the tube 80 shrinks and volume A slightly decreases due to a lower pressure in portion B of the line). The flow rate decreases slightly through the instrument cutter opening as well. This occurs as the volume of portion B of the line 80 decreases (tubing shrinks) due to lower pressure inside generated by increased resistance at the instrument opening.

When the resistance at the opening C increases further and the pump is still moving at a set speed, evacuating the fluid suspension from volume B, then the pressure in volume B decreases further. If this process continues the column of liquid in portion of the tubing B will break and form spaces of low pressure vapors or even vacuum. And if there is any air or other gases dissolved in the suspension, they will start to separate and their volume will increase as pressure in volume B drops further.

So far no damage was done to the eye. Exit of the infusion solution is blocked, the eye is formed and its inside pressure is at its maximum desired level. If the resistance at the instrument opening would decrease slowly and gradually. which seldom happens, then the flow from the eye will resume and increase gradually until volume B is filled up again. The outflow from the eye is matched by the inflow so the eye stays formed. The flow will then stabilize at a changing level. In a more typical case, the resistance decreases momentarily, e.g. because the instrument opening is unblocked, and the volume B, which is partially or totally empty, fills up in a short time. The flow out of the eye is then greater than the flow in the eye. The eye loses its desired pressure and it will soften and collapse. Also, portions of healthy tissue of the eye may enter the cutter opening of the instrument with disastrous effects.

To prevent this from occurring with the described system, it is imperative to prevent prohibitive reduction of volume or density of the fluid suspension in volume B of the evacuating line 80. This is achieved by keeping B small and its inside pressure relatively high. Short tubings with a small inner diameter will provide the small volume. The change in volume in relation to the original volume will be small if the tubing is made of rigid material (metal, or thick wall flexible plastic tubins, for example, TYGON).

When the critical pressure (at which cohesive forces in the liquid column are exceeded) is reached, the liquid column will break and liquid-less spaces can be noticed through the wall of a clear flexible plastic tubing. The pressure level at which this separation takes place depends on the consistency of the liquid suspension and its temperature, but it can be clearly established for a given case. This pressure level can be observed on a pressure (suction) gauge and the pump can be stopped before it reaches the undesired level. The liquid column will not break and gases will not separate if pressure in volume B is kept above a given level. This may be achieved by stopping the pump prior the critical pressure is reached.

Separation of gases from the liquid suspension is a third disturbing factor (the first, shrinkage of tubing, the second, breakage of liquid column). Gases dissolved in liquid can be separated at a given (room) temperature if pressure on and in the liquid is decreased. As before, when pressure in a clear plastic tubing is sufficiently reduced, at first a small quantity of very small gas bubbles appear in the liquid and as pressure is further reduced the number and size of the bubbles increases. The pressure at which the separation starts to be apparent can be observed on a pressure gauge and if the pump is stopped before the pressure reaches the undesired value, the separation will not occur. If some small degree of separation occurs it will not be harmful in terms of the problem described.

In either case if breaking of the column or fluid or separation of gases, pump 81 can be stopped manually if and when the observed conditions in portion of the line B visually appear to become critical. Pump also can be stopped automatically, for example, pressure transducer 82 regulates the pressure in line 80. The transducer 87 produces a signal which is supplied to control circuit 96. If the pressure in line 80 falls below a predetermined minimum value, which can be selected and preset into the evacuation control circuit 96, the latter circuit produces an output signal which shuts off mechanism 81. In a typical embodiment of the invention, this is designed to occur when the pressure in evacuation line 80 is at between about to 760 mm of Hg below atmosphereic pressure. This is a safety feature of the system.

When, and if, the flow from the eye through the cutter opening 19 of the instrument resumes (or increases) the pressure in volume B will increase and the pump can be started again, manually or automatically. In the latter case, the evacuation control circuit produces an output signal in response to the pressure sensed by 9 transducer 82 to start the mechanism 81 again. A 10% pressure margin between OFF and ON has been found to be satisfactory.

If flow of liquid from the eye stops, or is reduced due to the blockage of evacuation port l9, or the viscosity of the tissue, entering the port 19 is increased, then the pressure in line 80 drops and transducer 87 triggers the control circuit 96 to stop mechanism 81. The pump 120 is stopped and since the-portion B of line 80 is not occupied by expanding or compressive spaces which are empty or filled up with rarefactored gases, the flow from the eye will stop soon after the pump is stopped. The delay time depends on the difference in pressure in line 80 and in the eye, since the shrinkage of volume B depends on the magnitude of this differential pressure. When the pump is stopped and flow continues out of the eye until pressure in the eye is equalized with the pressure in line B.

In order to prevent a flow of liquid from the eye after the pump is stopped, liquid should be brought in portion B of line 80 from the reverse flow line 70 until equilibrium is achieved between pressure in the eye and pressure in portion B. This is done by opening the reverse flow control valve 69 when the evacuation process is stopped. Valve 69 is normally closed during the evacuation process. It also can be closed during the ready mode when the pressure in the evacuation line approaches or is equal to the pressure in the eye.

As an alternative the pump .120 could be turned in the opposite direction to deliver liquid and increase the pressure in portion B of line 80 until equilibrium between the pressure in the eye and the pressure in portion B is achieved. Turning of the pump in the opposite direction can be accomplished by operating a specific switch by hand and keeping the pump running until the observed pressure reaches a specific value on a pressure gauge in line 80. It also can be done automatically as the pump is being de-energized from providing fluid flow from the eye it can be energized to produce a reverse flow until a predetermined value of pressure or equilibrium between pressure in they eye and pressure in portion B of line 80 is reached. The reverse flow into portion B of evacuation line 80 is produced by a fixed or adjustable pressure in the bottle 60 until the pressure ,in the portion B has reached a desired fixed or adjustable value. This is determined by the transducer 87 and 'circuit control 96. As another alternative, when the operation is being performed in an open eye, the adjusted or adjustable flow is made to take place for a fixed or adjustable length of time.

The same result obtained by reversing the pump, either automatically ormanually, can beaccomplished by opening the. clamping mechanism of the pump so i the eye it is impossible to define and keep "track of its internal pressure at any and every particular instance during the operation. Thus, equilibrium between pres,- sure in portion B of the evacuation line 80 and the eye is never really reached when the pump is turned back- 10 ward. The accommodation of restoring pressure in portion B of the evacuation line should be to minimize and not eliminate entirely the flow from the eye after the flow is not desired or needed any longer, and the pump 120 is deactivated.

3. Reverse flow mode This is obtained by the operator moving the control switch to another position, illustratively backwards on the foot switch. When this is done, the electrical controls are set up such that direction of rotation of the instrument cutter motor is reversed and the evacuation mechanism 81 is stopped. Pressure valves 58a and 58b are closed and valve 58c is left open to set up the reverse pressure in line 70. The infusion line control valve 68 is closed and the reverse flow line control valve 69 is opened.

The high pressure flow of reverse flow fluid is supplied from bottle 60 to line 70 and to the opening 19 for the cutter in the instrument 10 to push away any material that might have clogged this opening or inadvertently entered the cutter opening.

A fourth mode of flow is created through the reverse flow line 70 after the evacuation process through line is terminated. This equalizes the pressure on both sides of the evacuating port of the instrument which is in the operating field.

In accordance with the general principle of the invention, if desired, the infusion fluid can be supplied to the instrument over a separate supply line during the reverse flow mode and a separate pump can be used for the reverse flowmode. The separate pump and supply line can also have its own control circuit so that the pressure in the line will not be excessive.

As a further alternative one or two of the valves 58a, 58b or 58c can be eliminated. For example, valve 58a could be removed and the ready mode pressure is controlled by valve 58b at the operating pressure. Further, only valve 58b could be used so that line 64 would have the same pressure during all three modes of operation. Neither one of these alternatives is as desirable as having the three valves.

The pressure in infusion bottle 60 also can be produced, maintained or changed by a system having a displacement type pump (e.g. a peristaltic or other suitable pump) for determining the amount of air pressed into the bottle or removed from it in order to maintain or regulate the desired pressure in the bottle at all stages of operation. This would be in response to control signals produced by the pressure transducer. A safety pressure valve is preverably used to prevent unwanted increases in pressure of the electronic circuit.

What is claimed is:

1. A system for use with a surgical instrument having an operative part at an operating site comprising:

means for supplying an infusion fluid under pressure to said operating site, 1

means for evacuating fluid with other material entrained therein from said operating site,

means for measuring the pressure of the infusion means for measuring the pressure of the evacuated fluid and other material,

and means responsive to a predetermined measured pressure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site.

2. A system as in claim 1 further comprising means for visually displaying the measured pressure of the infusion fluid.

.3. A system as in claim 1 further comprising means for visually displaying the measured pressure of the evacuation fluid.

4. A system as in claim 1 further comprising means for setting said predetermined pressure at which the evacuation of the fluid from the operating site is terminated.

5. A system as in claim 1 wherein said means for supplying said infusion fluid to and said means for evacuat- 12 said instrument, said operating means includes means for a. stopping said motor when both said first and second control means are open, b. rotating said motor in a first direction when only said first control means is open, and c. rotating said motor in a second direction when only said second control means is open. 14. A system for use with a surgical instrument having fluid from said operating site include a portion of g an Operative P at an Operating Site Comprising:

said instrument at the operating site.

6. A system as in claim 1 wherein said means for evacuating fluid from the operating site includes a peristaltic pump.

7. A system for use with a surgical instrument having an operative portion at an operating site comprising:

means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site,

means for evacuating fluid with material entrained therein from said operating site through said instrument.

means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid,

and means including second control means and a portion of said means for evacuating fluid from the operating site in fluid communication with said evacuation means to supply a further fluid through said instrument to said operating site.

8. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for stopping said motor and operating said first and second control means to supply siad infusion fluid and said further fluid to said operating site.

9. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for rotating said motor in a second direction and operating said first and second control means to supply only said further fluid to said operating site.

10. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for stopping said motor and operating said first and second control means to supply said infusion fluid and said further fluid to said operating site.

ll. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for rotating said motor in a second direction and operating said first and second control means to supply only said further fluid to said operating site.

12. Apparatus as in claim 7 further comprising means for operating said first and second control means to selectively:

a. open said first and second control means to permit the supply of both said infusion fluid and said further fluid to said operating site,

b. to open only said first control means to permit only the supply of infusion fluid to said site, or

c. to open only said second control means to permit only the supply of the further fluid to said site.

13. Apparatus as in claim 12 further comprising a reversible motor for a part of the operative portion of means for supplying an infusion fluid under pressure to said operating site,

means for evacuating fluid with other material entrained therein from said operating site,

means for measuring the pressure of the infusion means for measuring the pressure of the evacuated fluid and other material,

and means for referencing the pressures measured to the pressure at the operating site.

15. A system as in claim 14 further comprising means responsive to a predetermined measured pres sure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site.

16. A system as in claim 15 wherein said means for evacuating fluid from the operating site includes a peristaltic pump.

17. A system for use with a surgical instrument having an operative portion at an operating site comprising:

means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site,

means for measuring the pressure of said infusion fluid,

means for evacuating fluid with material entrained therein from said operating site through said instrument,

means for measuring the pressure of the evacuated fluid,

and means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid.

18. A system as in claim 17 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for controlling the rotation of said motor in a first direction with said first control means open to permit the infusion fluid to be supplied to the operating site.

19. Apparatus as in claim 17 further comprising means including second control means and a portion of said means for evacuating fluid from the operating site in fluid communication with said evacuation means to supply a further fluid through said instrument to said operating site.

20. Apparatus as in claim 19 further comprising means for operating said first and second control means to selectively:

a. open said first and second control means to permit the supply of both said infusion fluid and said further fluid to said operating site,

b. to open only said first control means to permit only the supply of infusion fluid to said site, or

c. to open only said second control means to permit only the supply of the further fluid to said site.

21. Apparatus as in claim 9 further comprising a reversible motor for a part of the operative portion of 13 said instrument, said operating means includes means for:

a. stopping said motor when both said first and second control means are open,

b. rotating said motor in a first direction when only said first control means is open, and

c. rotating said motor in a second direction wherein only said second control means is open.

22. A system for use with a surgical instrument having an operative part at an operating site comprising:

means for supplying an infusion fluid under pressure to said operating site,

means for evacuating fluid with other material entrained therein from said operating site,

means for measuring the pressure of the evacuated fluid and other material,

and means responsive to a predetermined measured pressure for terminating the evacuation of fluid from the operating site.

23. Apparatus as in claim 22 further comprising means for setting the predetermined measured pressure at which the evacuation is stopped.

24. A system for use with a surgical instrument having an operative part at an operating site comprising:

means for supplying an infusion fluid under pressure to said operating site,

means for evacuating fluid with other material entrained therein from said operating site,

means for measuring the pressure of the evacuated fluid and other material,

means responsive to a predetermined measured pressure for terminating the evacuation of fluid from the operating site, and

means for building up the pressure in said means for evacuation after the evacuation is terminated.

25. Apparatus as in claim 24 further comprising means for reversing the flow of fluid and material in said evacuation means.

26. Apparatus as in claim 24 further comprising means for venting said evacuation to another pressure after the evacuation is terminated.

27. Apparatus as in claim 25 wherein the venting takes place at atmosphereic pressure.

28. A system for use with a surgical instrument having an operative portion at an operating site comprising:

means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site,

means for evacuating fluid'with material entrained therein from said operating site through said instrument,

means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid,

a motor for rotating at least a part of said operative portion of said instrument,

and means for controlling the rotation of said motor in a first direction with said first control means open to permit the infusion fluid to be supplied to the operating site.

29. A system for use with a surgical instrument having an operative portion at an operating site comprismg: a

means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site,

means for evacuating fluid with material entrained therein from said operating site through said instrument,

means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid,

means for measuring the pressure of the infusion means for measuring the pressure of the evacuated fluid and other material,

and means responsive to a predetermined measured pressure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site. 

1. A system for use with a surgical instrument having an operative part at an operating site comprising: means for supplying an infusion fluid under pressure to said operating site, means for evacuating fluid with other material entrained therein from said operating site, means for measuring the pressure of the infusion fluid, means for measuring the pressure of the evacuated fluid and other material, and means responsive to a predetermined measured pressure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site.
 2. A system as in claim 1 further comprising means for visually displaying the measured pressure of the infusion fluid.
 3. A system as in claim 1 further comprising means for visually displaying the measured pressure of the evacuation fluid.
 4. A system as in claim 1 further comprising means for setting said predetermined pressure at which the evacuation of the fluid from the operating site is terminated.
 5. A system as in claim 1 wherein said means for supplying said infusion fluid to and said means for evacuating fluid from said operating site include a portion of said instrument at the operating site.
 6. A system as in claim 1 wherein said means for evacuating fluid from the operating site includes a peristaltic pump.
 7. A system for use with a surgical instrument having an operative portion at an operating site comprising: means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site, means for evacuating fluid with material entrained therein from said operating site through said instrument, means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid, and means including second control means and a portion of said means for evacuating fluid from the operating site in fluid communication with said evacuation means to supply a further fluid through said instrument to said operating site.
 8. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for stopping said motor and operating said first and second control means to supply siad infusion fluid and said further fluid to said operating site.
 9. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for rotating said motor in a second direction and operating said first and second control means to supply only said further fluid to said operating site.
 10. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for stopping said motor and operating said first and second control means to supply said infusion fluid and said further fluid to said operating site.
 11. A system as in claim 7 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for rotating said motor in a second direction and operating said first and second control means to supply only said further fluid to said operating site.
 12. Apparatus as in claim 7 further comprising means for operating said first and second control means to selectively: a. open said first and second control means to permit the supply of both said infusion fluid and said further fluid to said operating site, b. to open only said first control means to permit only the supply of infusion Fluid to said site, or c. to open only said second control means to permit only the supply of the further fluid to said site.
 13. Apparatus as in claim 12 further comprising a reversible motor for a part of the operative portion of said instrument, said operating means includes means for a. stopping said motor when both said first and second control means are open, b. rotating said motor in a first direction when only said first control means is open, and c. rotating said motor in a second direction when only said second control means is open.
 14. A system for use with a surgical instrument having an operative part at an operating site comprising: means for supplying an infusion fluid under pressure to said operating site, means for evacuating fluid with other material entrained therein from said operating site, means for measuring the pressure of the infusion means for measuring the pressure of the evacuated fluid and other material, and means for referencing the pressures measured to the pressure at the operating site.
 15. A system as in claim 14 further comprising means responsive to a predetermined measured pressure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site.
 16. A system as in claim 15 wherein said means for evacuating fluid from the operating site includes a peristaltic pump.
 17. A system for use with a surgical instrument having an operative portion at an operating site comprising: means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site, means for measuring the pressure of said infusion fluid, means for evacuating fluid with material entrained therein from said operating site through said instrument, means for measuring the pressure of the evacuated fluid, and means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid.
 18. A system as in claim 17 wherein said instrument includes a motor for rotating at least a part of said operative portion of said instrument, means for controlling the rotation of said motor in a first direction with said first control means open to permit the infusion fluid to be supplied to the operating site.
 19. Apparatus as in claim 17 further comprising means including second control means and a portion of said means for evacuating fluid from the operating site in fluid communication with said evacuation means to supply a further fluid through said instrument to said operating site.
 20. Apparatus as in claim 19 further comprising means for operating said first and second control means to selectively: a. open said first and second control means to permit the supply of both said infusion fluid and said further fluid to said operating site, b. to open only said first control means to permit only the supply of infusion fluid to said site, or c. to open only said second control means to permit only the supply of the further fluid to said site.
 21. Apparatus as in claim 9 further comprising a reversible motor for a part of the operative portion of said instrument, said operating means includes means for: a. stopping said motor when both said first and second control means are open, b. rotating said motor in a first direction when only said first control means is open, and c. rotating said motor in a second direction wherein only said second control means is open.
 22. A system for use with a surgical instrument having an operative part at an operating site comprising: means for supplying an infusion fluid under pressure to said operating site, means for evacuating fluid with other material entrained therein from said operating site, means for measuring the pressure of the evacuated fluid and other material, and means responsive to a predeteRmined measured pressure for terminating the evacuation of fluid from the operating site.
 23. Apparatus as in claim 22 further comprising means for setting the predetermined measured pressure at which the evacuation is stopped.
 24. A system for use with a surgical instrument having an operative part at an operating site comprising: means for supplying an infusion fluid under pressure to said operating site, means for evacuating fluid with other material entrained therein from said operating site, means for measuring the pressure of the evacuated fluid and other material, means responsive to a predetermined measured pressure for terminating the evacuation of fluid from the operating site, and means for building up the pressure in said means for evacuation after the evacuation is terminated.
 25. Apparatus as in claim 24 further comprising means for reversing the flow of fluid and material in said evacuation means.
 26. Apparatus as in claim 24 further comprising means for venting said evacuation to another pressure after the evacuation is terminated.
 27. Apparatus as in claim 25 wherein the venting takes place at atmosphereic pressure.
 28. A system for use with a surgical instrument having an operative portion at an operating site comprising: means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site, means for evacuating fluid with material entrained therein from said operating site through said instrument, means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid, a motor for rotating at least a part of said operative portion of said instrument, and means for controlling the rotation of said motor in a first direction with said first control means open to permit the infusion fluid to be supplied to the operating site.
 29. A system for use with a surgical instrument having an operative portion at an operating site comprising: means including first control means for supplying an infusion fluid under pressure through said instrument to said operating site, means for evacuating fluid with material entrained therein from said operating site through said instrument, means for selectively operating said first control means to open and close said control means to thereby permit or stop the supply of the infusion fluid, means for measuring the pressure of the infusion fluid, means for measuring the pressure of the evacuated fluid and other material, and means responsive to a predetermined measured pressure difference between the evacuated fluid and the infusion fluid for terminating the evacuation of fluid from the operating site. 